In a significant breakthrough in the fight against tuberculosis (TB), the World Health Organization (WHO) has granted prequalification to the Xpert® MTB/RIF Ultra test. This is the first-ever diagnostic tool for tuberculosis and antibiotic susceptibility testing to meet the WHO’s rigorous prequalification standards, offering a new ray of hope for global TB diagnosis and treatment.
Tuberculosis remains one of the deadliest infectious diseases worldwide, claiming the lives of over a million people annually. It poses a particularly heavy burden in low- and middle-income countries, where the availability of high-quality diagnostic tools has often been limited. Timely detection of TB, especially multidrug-resistant (MDR) and rifampicin-resistant strains, is crucial for effective treatment and containment, but it has long been a challenge for health systems, particularly in resource-limited settings.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized the importance of this milestone: “This first prequalification of a diagnostic test for tuberculosis marks a critical milestone in WHO’s efforts to support countries in scaling up and accelerating access to high-quality TB assays. These tests meet both WHO recommendations and its stringent quality, safety, and performance standards.” She noted that such innovations are essential in addressing one of the world’s deadliest diseases, underscoring the global health community’s push for better diagnostic tools.
The Xpert® MTB/RIF Ultra test, developed by Cepheid Inc., is a nucleic acid amplification test (NAAT) designed to detect the genetic material of Mycobacterium tuberculosis—the bacterium responsible for TB—in sputum samples. What makes this test particularly groundbreaking is its ability to simultaneously identify mutations associated with rifampicin resistance, an early indicator of MDR-TB. The test produces accurate results within a few hours, significantly reducing the time between diagnosis and the initiation of treatment.
WHO’s prequalification of this diagnostic test is poised to enhance the global response to TB by ensuring that diagnostic tools meet international standards of quality and safety. The prequalification process assures countries that the tests used in diagnosing and treating TB are not only accurate but also equitable and accessible to the populations who need them most.
“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”
The prequalification of the Xpert® MTB/RIF Ultra test is the first step in WHO’s ongoing commitment to improving global access to TB diagnostics. This tool complements WHO’s endorsement approach, which considers diagnostic accuracy, patient outcomes, accessibility, and equity. It also aligns with the organization’s broader mission to enhance health care access in resource-poor settings.
In addition to this achievement, WHO is actively assessing several other TB tests to expand the available diagnostic options for countries worldwide. The organization’s collaboration with regulatory authorities, such as Singapore’s Health Sciences Authority (HSA), strengthens the credibility and global reach of prequalified products. Currently, WHO is reviewing seven additional TB tests, aiming to broaden diagnostic availability and ensure that countries have a diverse range of reliable tools at their disposal.
As TB remains a major global health challenge, innovations like the Xpert® MTB/RIF Ultra test represent vital steps toward more efficient diagnosis and treatment, offering hope for millions of people affected by this devastating disease. The WHO’s efforts to prequalify TB diagnostic tests reflect a deeper commitment to fighting not just tuberculosis, but also the complex issue of drug resistance that complicates treatment outcomes globally.
